Electronic Patient-reported Outcome Monitoring in Patients With Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- usability of the ePRO application
研究概览
简要总结
Aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) are interrelated and very rare diseases. Therefore, little data about clinical characteristics, especially the variety of symptoms in the course of the respective disease are available. As a consequence, patients may be left on their own between infrequent follow-ups at a specialist center. A web-based symptom-monitoring application can support selfmanagement and patient empowerment and promotes a patient- centered interdisciplinary team approach in the context of a "disease management program". This pilot study is to investigate usability and feasibility of the electronic Patient-Reported Outcome (ePRO) application in AA/PNH by assessing recruitment, app utilization, data collection, functionality, acceptability after using and working with the ePRO application.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AA (acquired and hereditary) and/or PNH patients
- •Minimal level of computer literacy with prior email experience and access to an Internet connection
排除标准
- •Mental alteration or psychiatric disease that can compromise written informed consent or adherence to the protocol and monitoring of the trial
结局指标
主要结局
usability of the ePRO application
时间窗: Weekly assessments from Day 1= Day of inclusion until Day 180 (+/- 7 days) = last day of testing phase
Descriptive analyses of usability of the ePRO application by assessing data collection with the ePRO application
recruitment with the ePRO application (number)
时间窗: Day 1= Day of inclusion
Analyses of usability of the ePRO application by assessing recruitment with the ePRO application
acceptability of the ePRO application
时间窗: Weekly assessments from Day 1= Day of inclusion until Day 180 (+/- 7 days) = last day of testing phase
Descriptive analyses of acceptability of the ePRO application by assessing app utilization
次要结局
- Change in quality of life assessed by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 questionnaire (EORTC QLQ-C30 questionnaire)(at day 1= Day of inclusion and at day 180 (+/- 7 days) = last day of testing phase)